Cy­to­ki­net­ics gets the Roy­al­ty treat­ment, snag­ging up to $450M to sup­port close­ly watched heart pro­grams

Cy­to­ki­net­ics stum­bled a bit with its close­ly watched lead heart drug over the last year or so, los­ing two phar­ma part­ners af­ter miss­ing a key sec­ondary end­point in a Phase III study. But things are look­ing up in 2022, as Roy­al­ty Phar­ma is reach­ing a lit­tle deep­er in­to its wal­let to bol­ster that pro­gram and an­oth­er heart can­di­date.

Roy­al­ty Phar­ma has agreed to lend up to $300 mil­lion to sup­port the po­ten­tial com­mer­cial­iza­tion of Cy­to­ki­net­ics’ lead can­di­date, ome­cam­tiv mecar­bil, and de­vel­op­ment of its oth­er heart pro­gram, afi­camten. The cash will come in five tranch­es, in­clud­ing an ini­tial tranche of $50 mil­lion up­on clos­ing and four oth­ers up­on cer­tain reg­u­la­to­ry and clin­i­cal mile­stones. Each tranche has an in­ter­est-free and pay­ment-free pe­ri­od of six cal­en­dar quar­ters, fol­lowed by 34 cal­en­dar quar­ters of in­stall­ment re-pay­ments to­tal­ing 1.9 times the amount drawn.

In ad­di­tion, Roy­al­ty is putting down $50 mil­lion up­front and an­oth­er $100 mil­lion in biobucks for a roy­al­ty on afi­camten of 4.5% on sales up to $1 bil­lion and 3.5% on sales above $1 bil­lion, sub­ject to cer­tain po­ten­tial step-downs.

Cy­to­ki­net­ics’ stock $CYTK was down near­ly 4% on Fri­day morn­ing, with shares pric­ing in at $37.25 apiece.

Robert Blum

The deal ex­pands on a “fruit­ful re­la­tion­ship” that dates back to 2017, ac­cord­ing to Cy­to­ki­net­ics CEO Robert Blum, when Roy­al­ty bought a 4.5% roy­al­ty on world­wide sales of ome­cam­tiv mecar­bil for $90 mil­lion and bought an­oth­er $10 mil­lion worth in eq­ui­ty.

“Our his­to­ry has taught us that do­ing a deal opens the door on an­oth­er deal,” Blum said dur­ing an in­vestor call on Fri­day, adding that the com­pa­ny is con­sid­er­ing go­ing af­ter part­ner­ships in oth­er ter­ri­to­ries like Japan and Eu­rope.

Just a cou­ple of weeks ago, the South San Fran­cis­co biotech an­nounced an ex­pand­ed part­ner­ship with Shang­hai biotech Ji Xing Phar­ma­ceu­ti­cals to de­vel­op and com­mer­cial­ize ome­cam­tiv mecar­bil in Chi­na, Hong Kong, Macau and Tai­wan.

“It was our goal to com­plete a struc­tured fi­nanc­ing trans­ac­tion to fur­ther bol­ster our bal­ance sheet to sup­port the de­vel­op­ment and ex­pan­sion of our car­dio­vas­cu­lar pro­grams and po­ten­tial fran­chise,” Blum said. “To­day’s an­nounce­ment puts a punc­tu­a­tion point on a struc­tured fi­nanc­ing deal cam­paign that we launched last year, and which ul­ti­mate­ly had us ac­tive­ly en­gag­ing with over a dozen dif­fer­ent in­vest­ment funds, most of which we took in­to de­tailed dis­cus­sions of terms.”

Fif­teen years af­ter en­ter­ing the clin­ic, Cy­to­ki­net­ics read out the Phase III da­ta for ome­cam­tiv mecar­bil back in No­vem­ber 2020. The drug tech­ni­cal­ly worked, meet­ing its pri­ma­ry end­point, but it flopped on a key sec­ondary end­point — re­duc­tion of car­dio­vas­cu­lar death. Am­gen shrugged off its 14-year al­liance with Cy­to­ki­net­ics just over a week lat­er. Then in May, Astel­las walked out of its own part­ner­ship on skele­tal sar­com­ere ac­ti­va­tors for dis­eases as­so­ci­at­ed with mus­cle weak­ness.

Cy­to­ki­net­ics re­turned that same month with post-hoc da­ta (which can be a dif­fi­cult sell at the FDA) sug­gest­ing ome­cam­tiv mecar­bil works bet­ter in sick­er pa­tients. In the analy­sis, Cy­to­ki­net­ics sep­a­rat­ed pa­tients from the Phase III GALAC­TIC-HF study in­to four quar­tiles based on ejec­tion frac­tion, a mea­sure­ment of how well the left ven­tri­cle pumps blood with each heart­beat. Pa­tients in the low­er two quar­tiles — those with an EF of 22% or low­er, and be­tween 29% to 32% — saw a 15% and 17% rel­a­tive risk re­duc­tion of heart fail­ure events and car­dio­vas­cu­lar death com­bined, Cy­to­ki­net­ics re­port­ed at ACC. No dif­fer­ence was seen in the up­per two quar­tiles.

The com­pa­ny had said it hoped to sub­mit an NDA in Q4 2021, though no fur­ther up­dates have been giv­en.

“We ex­pect to com­ment up­on its po­ten­tial ac­cep­tance with the FDA,” a spokesper­son told End­points News on Fri­day.

Then there’s afi­camten, Cy­to­ki­net­ics’ car­diac myosin in­hibitor tar­get­ing hy­per­trophic car­diomy­opa­thy (HCM). Cy­to­ki­net­ics read out some pos­i­tive Phase II da­ta back in Ju­ly, show­ing pa­tients tak­ing the can­di­date for 10 weeks saw “sub­stan­tial and sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions” from base­line in the av­er­age rest­ing left ven­tric­u­lar out­flow tract pres­sure gra­di­ent (LVOT-G) and the av­er­age post-Val­sal­va LVOT-G, com­pared to place­bo.

That drug is in main com­pe­ti­tion with Bris­tol My­ers Squibb’s mava­camten, which was hit with a ma­jor set­back in No­vem­ber when the FDA ex­tend­ed its PDU­FA date three months, from Jan. 28 to April 28.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.